Breast Cancer FemaleEXERT-BCNCT05747209
EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA
An observational study of Breast Cancer Female, run by Colin Champ, MD at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. Read more about this study
- Who is it for?
- Ages 20 to 89 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Observation of Exercise Program Adherence
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 19 Sep 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females aged 20-89 years with newly diagnosed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast who have undergone and completed treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.
Who may be able to join
- Age 20-89 years
- Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
- Participants must have abstained from smoking for at least 12 months
- Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
- Participants must be determined capable of engaging in resistance training.
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- Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
- Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel.
- Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI
- Participants must be able to get down and up from the ground and squat their body weight.
Who cannot join
- Any treatment with chemotherapy for breast cancer
- Inability to get and down off the ground or squat body weight
- Inability to safely engage in group sessions
- Severe arthritic, joint, cardiovascular, or musculoskeletal condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer
The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:
- Is resistance training feasible following breast cancer treatment
- Can it improve the body's mobility and strength lost as a result of the breast cancer treatment
- can it improve the body's composition (for example muscle mass)
- can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.
Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.
Read the detailed description
Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations.
This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate.
The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.
- Conditions
- Breast Cancer Female
- Being tested
- Observation of Exercise Program Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of Exercise Program AdherenceOther
Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Standard High-load resistance training | Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. Receives: Other: Observation of Exercise Program Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Attendance
Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%.
Measured: Baseline and Three (3) months
Change in Adipose Tissue (InBody, kg)
Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR).
Measured: Baseline and Three (3) months
Change in Adipose Tissue (Ultrasound, Lbs)
Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR).
Measured: Baseline and Three (3) months
Change in Muscle Mass
Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months.
Measured: Baseline and Three (3) months
Change in Fat-Free Mass
Changes in percent fat-free mass (measured by ultrasound) from baseline to three months.
Measured: Baseline and Three (3) months
Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine.
Measured: Baseline and Three (3) months
Activity Levels Via Godin Questionnaire
Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary
Measured: 3 months
Resting Metabolic Rate as Calories Burned Per Day
Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis.
Measured: Baseline and Three (3) months
Functional Movement Screen
A functional movement screen will be performed pre and post regimen to assess change in overall score
Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of "if any pain felt by the subject during the movement", "subject is unable to perform the movement", "subject performs the movement through compensatory movements", and "subject performs the movement correctly", respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome.
Measured: Baseline and Three (3) months
Y-balance Score
A Y-balance test will be performed pre and post regimen to assess change
Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
Measured: Baseline and Three (3) months
Changes in Strength From Baseline Through Study Completion, up to 3 Months
Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3.
Measured: Baseline and months 1, 2, and 3
Secondary outcomes (1)
Participants Will Undergo an Assessment 1 Year Following the Exercise Program.
Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Oct 2022
- Primary completion13 Aug 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Colin Champ, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Colin Champ, MD, Principal investigator, AGH Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747209
- Sponsor's protocol ID
- EXERT-BC
- Acronym
- EXERT-BC
- Status last verified
- Jun 2025
- First submitted
- 2 Nov 2022
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpenter DJ, Peluso C, Hilton C, Velasquez F, Annichine A, Matsko K, Rosenberg J, Diaz AK, Hyde P, Beriwal S, Champ CE. EXERT-BC: A pilot study of an exercise regimen designed to improve functional mobility, body composition, and strength after the treatment for breast cancer. Cancer Med. 2024 Mar;13(5):e7001. doi: 10.1002/cam4.7001.
PubMed 38491821
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT05747209
- Acronym / sponsor ID
- EXERT-BC / EXERT-BC
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Colin Champ, MDUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:
- Is resistance training feasible following breast cancer treatment
- Can it improve the body's mobility and strength lost as a result of the breast cancer treatment
- can it improve the body's composition (for example muscle mass)
- can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.
Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.
Detailed description
Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations.
This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate.
The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard High-load resistance training | – | Other: Observation of Exercise Program AdherenceStandard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females aged 20-89 years with newly diagnosed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast who have undergone and completed treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.
Key inclusion criteria (10 listed)
- Age 20-89 years
- Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
- Participants must have abstained from smoking for at least 12 months
- Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
Key exclusion criteria (4 listed)
- Any treatment with chemotherapy for breast cancer
- Inability to get and down off the ground or squat body weight
- Inability to safely engage in group sessions
- Severe arthritic, joint, cardiovascular, or musculoskeletal condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of Exercise Program AdherenceObservation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. | Other | Standard High-load resistance training |
Primary outcome
Session Attendance
Time frame: Baseline and Three (3) months
Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%.
Change in Adipose Tissue (InBody, kg)
Time frame: Baseline and Three (3) months
Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR).
Change in Adipose Tissue (Ultrasound, Lbs)
Time frame: Baseline and Three (3) months
Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR).
Change in Muscle Mass
Time frame: Baseline and Three (3) months
Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months.
Change in Fat-Free Mass
Time frame: Baseline and Three (3) months
Changes in percent fat-free mass (measured by ultrasound) from baseline to three months.
Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels
Time frame: Baseline and Three (3) months
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine.
Activity Levels Via Godin Questionnaire
Time frame: 3 months
Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary
Resting Metabolic Rate as Calories Burned Per Day
Time frame: Baseline and Three (3) months
Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis.
Functional Movement Screen
Time frame: Baseline and Three (3) months
A functional movement screen will be performed pre and post regimen to assess change in overall score Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of "if any pain felt by the subject during the movement", "subject is unable to perform the movement", "subject performs the movement through compensatory movements", and "subject performs the movement correctly", respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome.
Y-balance Score
Time frame: Baseline and Three (3) months
A Y-balance test will be performed pre and post regimen to assess change Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
Changes in Strength From Baseline Through Study Completion, up to 3 Months
Time frame: Baseline and months 1, 2, and 3
Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3.
1 secondary outcome
Participants Will Undergo an Assessment 1 Year Following the Exercise Program.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38491821Carpenter DJ, Peluso C, Hilton C, Velasquez F, Annichine A, Matsko K, Rosenberg J, Diaz AK, Hyde P, Beriwal S, Champ CE. EXERT-BC: A pilot study of an exercise regimen designed to improve functional mobility, body composition, and strength after the treatment for breast cancer. Cancer Med. 2024 Mar;13(5):e7001. doi: 10.1002/cam4.7001.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Champ, MD principal investigator
AGH Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Colin Champ, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Attendance (time frame: Baseline and Three (3) months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.